Psychobiological Pathways: Breast Cancer Interventions
RATIONALE: Meeting together with other breast cancer patients to receive psychosocial support and to learn to reduce stress may help patients cope with their diagnosis, have a better quality of life, and live more comfortably. PURPOSE: This randomized clinical trial is studying how well psychosocial support works in treating women with recurrent breast cancer or stage I, stage II, or stage IV breast cancer.
NCT00416780 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT00416780/
A Phase II Study of Simvastatin in Women at High Risk for a New Breast Cancer
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of simvastatin may keep cancer from coming back in women who are at high risk for a new breast cancer after undergoing surgery for ductal carcinoma in situ or stage I, stage II, or stage III breast cancer. PURPOSE: This phase II trial is studying how well simvastatin works in preventing a new breast cancer in women at high risk for a new breast cancer after undergoing surgery for ductal carcinoma in situ or stage I, stage II, or stage III breast cancer.
NCT00334542 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT00334542/
Transillumination for Breast Cancer Risk Assessment
This study aims to evaluate if a light based technique, called Transillumination Breast Spectroscopy (TIBS), can be used to construct a non-invasive breast cancer risk predictor which provides a better odds ratio than mammographic parenchymal density.
NCT00188721 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT00188721/
Fetal Microchimerism and Fetal Stem Cells in Breast Cancer: Analysis of Circulating Fetal Cell Sub-populations in Women With Breast Cancer. CIRCULATING FETAL CELLS AND Breast Cancer
After pregnancy, fetal cells remain in a woman's body for years. These cells may be involved in different physiological situations (e.g. wound healing) and diseases (e.g. cancer).The study will evaluate the level of circulating fetal immune cells in patients with breast cancer vs controls with benign breast tumors, and further characterize these fetal cells. Patients participation will be limited to accepting that an additional blood sample is collected on the day of their preop consultation and blood test.
NCT04903990 — Breast Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/breast-cancer/NCT04903990/
Basket Study for Oligo-metastatic Breast Cancer Part 1: Trastuzumab-deruxtecan for HER2-positive Oligo-metastatic Breast Cancer
The study will include patients with HER2-positive breast cancer and 1- 3 distant metastatic lesions, all amenable for curative intervention. Patients will be stratified by prior therapy and ER expression. In the initial baskets patients with be treated with trastuzumab-deruxtecan. Patients are treated with T-DXd 5.4mg/kg on a three weekly (21 day) basis, with the goal of 16 cycles leading to a treatment period of year, including local treatment. The first 8 cycles of T-DXd are administered neo-adjuvant, and 8 cycles adjuvant, after completion of local treatment. The proposed M22BOL trial is based on an important knowledge gap for regarding breast cancer patients with 'oligo-metastatic' disease who are usually not included in clinical trials for patients with metastatic disease since loco-regional treatments (radiation, surgery) with curative intent is not allowed in clinical trials for metastatic breast cancer. Moreover, neo-adjuvant trial protocols for early breast cancer exclude patients with distant metastases that can be treated with curative intent. This basket trial evaluates T-DXd for oligo-metastatic breast cancer with the goal to induce deep responses and subsequently long-lasting disease remissions and potentially cure.
NCT05982678 — HER2-positive Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/her2-positive-breast-cancer/NCT05982678/
Phase IIA Trial of Acolbifene (20 mg) vs Low Dose Tamoxifen (5 mg) in Pre-Menopausal Women at High Risk for Development of Breast Cancer
This phase IIA trial compares the effect of acolbifene versus low dose tamoxifen in preventing breast cancer in premenopausal women at high risk for developing breast cancer. The usual approach for patients at increased risk for breast cancer is to undergo yearly breast magnetic resonance imaging (MRI) or ultrasound in addition to yearly mammogram. Premenopausal women at very high lifetime risk for breast cancer (greater than 50%) can consider preventive removal (mastectomy) of both breasts. Premenopausal women age 35 or older with a prior diagnosis of atypical hyperplasia, lobular carcinoma in situ, or an estimated 10-year risk of greater than or equal to 3% or estimated 10-year risk of greater than or equal to 2-5 times that of the average woman (depending on age) may be advised to consider five years of standard dose tamoxifen. Standard dose tamoxifen is four times the dose used in this study. Estrogen can cause the development and growth of breast cancer cells. Acolbifene and tamoxifen blocks the use of estrogen by breast cells. This study may help researchers measure the effects of acolbifene and low dose tamoxifen on markers of breast cancer risk in mammogram imaging, breast tissue, and in blood samples.
NCT05941520 — Breast Carcinoma
Status: Not yet recruiting
http://inclinicaltrials.com/breast-carcinoma/NCT05941520/
The Effect of Breast Cancer Screening Training Given to Municipal Women on Health Literacy, Breast Cancer Screening Beliefs and Behaviors
The lack of knowledge of women on breast cancer and health literacy poses a major obstacle to people's breast cancer screening behaviors and beliefs. In order to increase social sensitivity and awareness on this issue; In particular, it is important to research, examine and examine how the municipalities and their employees, who are representatives of the society, evaluate breast cancer screening studies. The aim of our project is to evaluate the effect of breast cancer screening training given to women working in the municipality on health literacy, breast cancer screening belief and behavior. This study will be conducted in a randomized-controlled experimental design with women (n=120) working in a municipality in Istanbul Province between November 2022 and November 2023. Data will be obtained face-to-face using the Participant Information Form, the Health Literacy Scale and the Breast Cancer Screening Beliefs Scale. The women in the experimental group (n=60) will be given 16 hours of breast cancer screening training, two days a week, two hours a day (60 min+60 min) for four weeks, by the researchers. No application will be made to the control group (n=60). Follow-up evaluations of the research will be completed in the following six months. The Health Literacy Scale and Breast Cancer Screening Beliefs Scale will be re-administered to all women in the experimental and control groups at the first follow-up after three months and at the second follow-up after 6 months. The data will be analyzed with statistical methods and the effectiveness of the training will be evaluated. When the project is concluded; The results will be presented as an article in a national or international journal, or as an oral presentation at a national or international congress. It will be ensured that breast cancer screening training given to women working in the municipality will increase their level of health literacy, have a positive effect on breast cancer screening belief and behavior, and increase their awareness and knowledge level on this subject. In the long term, widespread effects such as reducing the costs women spend on breast cancer, reducing mortality and morbidity rates, raising a conscious society, training undergraduate students involved in the project, and helping them learn by experiencing the research conducted at the national level are foreseen.
NCT05723237 — Women's Health: Neoplasm of Breast
Status: Active, not recruiting
http://inclinicaltrials.com/women-s-health-neoplasm-of-breast/NCT05723237/
A Retrospective Non-interventional Study of Breast Cancer Patients Diagnosed With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib in Denmark
The objective is to retrospectively describe and assess clinical and demographical characteristics, treatment patterns in a real-world (RW) setting of patients with HR+/HER2- (hormone receptor positive/human epidermal growth factor receptor 2 negative) locally advanced or metastatic breast cancer receiving palbociclib in combination treatment
NCT05452798 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT05452798/
Treatment of Patients With Advanced Breast Cancer Harboring TP53 Mutations With Dose-dense Cyclophosphamide - the p53 Breast Cancer Trial
This is a multicenter, open labeled, phase 2 clinical trial, where patients are stratified to one of two treatment groups based on upfront TP53 mutation status; i.e. TP53 mutated vs. TP53 wt disease, and treated with dose-dense cyclphosphamide. Furthermore, patients included are stratified based on tumor stage; i.e. locally advanced breast cancer (M0 disease) or metastatic breast cancer (M1 disease). All participating cancer centers will prospectively include patients with breast cancer fulfilling the inclusion criteria. If patients do not respond to the experimental treatment as outlined in the protocol, treatment with dose-dense cyclophosphamide will be terminated, and further cancer treatment will continue at the treating oncologist's discretion. The response data for all patients who have received at least one chemotherapy course will be included in the final efficacy analysis. Tumor tissue, blood samples and radiology data will be collected before therapy starts, if therapy needs to be changed, and for patients with locally advanced breast cancer: at surgery. Response data will be evaluated closely during treatment, with clinical assessment of tumor size every two weeks for patients with locally advanced breast cancer and by radiology every eight weeks for patients with metastatic breast cancer. Evaluation of side effects/tolerance will be performed at every clinical visit, i.e. every two weeks for all patients included in the p53 trial.
NCT02965950 — Metastatic Breast Carcinoma
Status: Active, not recruiting
http://inclinicaltrials.com/metastatic-breast-carcinoma/NCT02965950/
Clinical Evaluation of LS-03M/LS-04R for the Detection of Sentinel Lymph Node Metastasis From Breast Cancer
The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the OSNA Breast Cancer System by comparing its performance to permanent section Hematoxylin and Eosin (H&E) and IHC staining.
NCT01136369 — Breast Neoplasms
Status: Completed
http://inclinicaltrials.com/breast-neoplasms/NCT01136369/